Sr. Manager, Quality Compliance, CAR T Manufacturing (R1556025-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Sr. Manager, Quality Compliance, CAR T plays a fundamental role in supporting and contributing to the execution of the quality compliance strategy for the Summit West S12 manufacturing site. The incumbent will work collaboratively with multiple departments across all functions and levels of the organization to provide strategic and tactical compliance support for the site. The incumbent will be responsible for leading site compliance activities involving health authorities, including evaluating significant quality events, leading fact finding meetings for significant quality events, communicating status of significant quality events to the Senior Leadership team and authoring compliance reports to health agencies (Biological Product Deviation Reports (BPDRs) and Product Defect Notifications and Recalls). In addition, the incumbent will lead and coordinate critical compliance activities within S12 – including gap assessments, commitments, and responses to audit and inspection findings – and ensure any quality risks identified are proactively mitigated.
Leads the Summit West (S12) Compliance team in the identification of Significant Events that may require a Notification to Management (NTM). Significant events are events that may impact quality of distributed product, disruption or significant delays in shipment to patients (e.g. Drug Shortage), market or field complaints deemed significant, and significant compliance events where Health Authority (HA) Notification is likely.
Leads / Hosts Fact Finding meetings on behalf of S12 manufacturing for any Significant Events, including hosting the meeting, solving issues of significance, proposing a path forward, issuing minutes and ensuring all documentation is recorded in the Quality Management System.
Issues Notifications to Management (NTM) for any Significant Events.
Authors compliance reports to regulatory agencies, including, for example, Biological Product Deviation Reports to FDA (BPDRs), Product Defect Notifications to EMA or Drug Shortage Notifications.
Communicates to site Senior Leadership Team regarding status of resolution, and interfaces with site external functions to drive resolution (e.g. Supplier Quality, Medical Affairs, Patient Safety, Regulatory Affairs, Global Quality Systems, etc.).
Partners with Quality, Medical Affairs and Patient Safety to ensure completion of Integrated Health Hazard Assessments (IHHAs), when necessary.
Ensures investigation of significant events are accurately communicated to the escalation team and apprises the escalation team of updates.
Leads and coordinates critical compliance activities within S12 – including gap assessments, commitments, responses to audit and inspection findings, and ensures risks are properly mitigates.
Participates in market recalls and mock recalls on behalf of S12.
Collaborates with other relevant line functions to prepare and review regulatory submission documents, registration dossiers, and responses to health authorities, in scope of submission or periodic GMP review, upon request.
Monitors compliance related processes (e.g. Product Quality Complaints, Notifications to Management, Mock Recall Assessments) to examine the overall health of the quality system in S12.
Ensure site’s inspection readiness and prepares the site for regulatory (health authority) inspections, provide front room and back room support and be responsible for generating response documentation.
Performs other Quality Compliance projects as required by management.
Bachelor’s degree in Science required; advanced degree preferred. Equivalent combination of education and experience will be considered.
6-8 years of experience within the biologic or pharmaceutical industry, including 3-5 years in regulatory and/or compliance.
Experience in CAR T or Biologics preferred.
Professional certification in Regulatory Affairs preferred.
Strong written and oral communication along with health authority communication skills; English language fluency.
Prior experience in a compliance role (e.g. Health Authority inspection management, inspection readiness, recall, Quality System remediation, QMS implementation, etc.).
Prior experience interacting with FDA or other regulatory agencies.
Ability to collaborate with personnel at all levels within and outside of the company.
Strong knowledge of multi-country cGMP regulations (e.g. U.S, EMA, Japan).
Must be able to interact with and influence multidiscipline departments and CTO sites.
Must possess an independent mindset and tenacity.
Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
Demonstrated proficiency in Microsoft Office applications.
Work is performed in a typical office environment, with standard office equipment available and used.
Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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